FDA.reportPublic FDA data

denileukin diftitox-cxdl 0.3 MG Injection [Lymphir]

RxCUI
2700756
RxNorm name
denileukin diftitox-cxdl 0.3 MG Injection [Lymphir]
Display name
denileukin diftitox-cxdl 0.3 MG Injection [Lymphir]
Full name
denileukin diftitox-cxdl 0.3 MG Injection [Lymphir]
Term type
SBD
Status
DailyMed mapping
Updated
2026-06-04 23:39:15

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761312Lymphirdenileukin diftitox-cxdl351(a)Rx2026-09-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LYMPHIRDENILEUKIN DIFTITOX-CXDLCitius Pharmaceuticals, Inc.ac3613d7-4304-40e7-a3f5-adb8a8adca5d2025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2700756

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 1 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
ac3613d7-4304-40e7-a3f5-adb8a8adca5dLYMPHIR 300 MCG Injection [PSN] · denileukin diftitox-cxdl 0.3 MG Injection [Lymphir] [SBD] · Lymphir 0.3 MG Injection [SY] · Lymphir 300 MCG Injection [SY]47These highlights do not include all the information needed to use LYMPHIR™ safely and effectively. See full prescribing information for LYMPHIR. LYMPHIR™ (denileukin diftitox-cxdl) for injection, for intravenous use Initial U.S. Approval: 202420250123